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510(k) K030269

GENICON CLIP APPLIER by Genicon, LC — Product Code FZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2003
Date Received
January 27, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

Other clearances by Genicon, LC

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  • K002542 — REUSABLE CANNULA (October 23, 2000)
  • K993625 — INSUFFLATION NEEDLE- 120MM, MODEL 900-200 (June 20, 2000)
  • K991382 — SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101 (July 15, 1999)
  • K982472 — GENICON TROCAR (February 4, 1999)

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  • K251054 — Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips (July 3, 2025)
  • K242541 — GEM ZIPCLIP (January 15, 2025)
  • K221495 — SOLID CLIP™ Single Use Clip Applier (July 18, 2024)
  • K232970 — Hem-o-lok® Ligating Clips (January 12, 2024)
  • K230966 — angiOCCLUDE Ligating Clips (September 19, 2023)
  • K232313 — LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endo (August 29, 2023)
  • K230480 — Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) (April 28, 2023)